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Buprenorphine
FDA Orange Book

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Buprenorphine

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 12 USDMF, 12 CEP/COS, 2 JDMF, 4 EU WC, 13 NDC API, 22 Listed Suppliers, $ API Reference Price

32 API Suppliers
12 USDMF
12 CEP/COS
2 JDMF
4 EU WC
13 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

16 Intermediates Suppliers

16 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

273 FDF Dossiers, 39 FDA Orange Book, 117 Europe, 6 Canada, 63 Australia, 7 South Africa, 41 Listed Dossiers

273 FDF Dossiers
39 FDA Orange Book
117 Europe
6 Canada
63 Australia
7 South Africa
41 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 10MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 15MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 20MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 5MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 7.5MCG/HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 10MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 15MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 20MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 5MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 7.5MCG/HR

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 12 SPI Pharma, 2 Seqens, 1 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 18 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 4 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

57 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 24 Controlled & Modified Release, 23 Direct Compression, 17 Taste Masking, 15 Granulation, 14 Thickeners and Stabilizers, 12 Chewable & Orodispersible Aids, 11 Solubilizers, 10 Co-Processed Excipients, 10 Parenteral, 10 Lubricants & Glidants, 8 Film Formers & Plasticizers, 7 Topical, 5 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Emulsifying Agents, 2 Coloring Agents, 1 Rheology Modifiers

57 Fillers, Diluents & Binders
42 Coating Systems & Additives
24 Controlled & Modified Release
23 Direct Compression
17 Taste Masking
15 Granulation
14 Thickeners and Stabilizers
12 Chewable & Orodispersible Aids
11 Solubilizers
10 Co-Processed Excipients
10 Parenteral
10 Lubricants & Glidants
8 Film Formers & Plasticizers
7 Topical
5 Disintegrants & Superdisintegrants
5 Empty Capsules
5 API Stability Enhancers
4 Vegetarian Capsules
4 Emulsifying Agents
2 Coloring Agents
1 Rheology Modifiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 194 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
194 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 94 Finished Drug Prices

1 US Medicaid Prescriptions
94 Finished Drug Prices

MARKET PLACE

11 APIs, 5 FDF Dossiers

11 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

96 US Patents, 7 US Exclusivities, 7 Health Canada Patents

96 US Patents
7 US Exclusivities
7 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 20 Others

2 EDQM
1 USP
20 Others

$ API Ref.Price (USD/KG) : 15,127 Xls

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01 5ALVOGEN

02 5AMNEAL

03 7BRAEBURN

04 5DIFGEN PHARMS

05 2INDIVIOR

06 5MYLAN TECH VIATRIS

07 5PURDUE PHARMA LP

08 5WATSON LABS TEVA

filter Dosage Reset all filters

39 All

01 30FILM, EXTENDED RELEASE;TRANSDERMAL

02 9SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS

filter Regulatory Info Reset all filters

39 All

01 6DISCN

02 33RX

filter Brand Name Reset all filters

39 All

01 7BRIXADI

02 25BUPRENORPHINE

03 5BUTRANS

04 2SUBLOCADE

filter RLD Reset all filters

39 All

01 25No

02 14Yes

Temad Buprenorphine

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01

WATSON LABS TEVA

BioFlorida Conference

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WATSON LABS TEVA

BioFlorida Conference

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RLD : No

TE Code : AB

BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 5MCG/HR

Approval Date : 2018-11-20

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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WATSON LABS TEVA

BioFlorida Conference

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WATSON LABS TEVA

BioFlorida Conference

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RLD : No

TE Code : AB

BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 10MCG/HR

Approval Date : 2018-11-20

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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WATSON LABS TEVA

BioFlorida Conference

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WATSON LABS TEVA

BioFlorida Conference

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RLD : No

TE Code : AB

BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 15MCG/HR

Approval Date : 2018-11-20

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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WATSON LABS TEVA

BioFlorida Conference

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WATSON LABS TEVA

BioFlorida Conference

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RLD : No

TE Code : AB

BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 20MCG/HR

Approval Date : 2018-11-20

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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WATSON LABS TEVA

BioFlorida Conference

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WATSON LABS TEVA

BioFlorida Conference

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RLD : No

TE Code : AB

BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 7.5MCG/HR

Approval Date : 2021-06-29

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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PURDUE PHARMA LP

BioFlorida Conference

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PURDUE PHARMA LP

BioFlorida Conference

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RLD : Yes

TE Code : AB

BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 5MCG/HR

Approval Date : 2010-06-30

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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PURDUE PHARMA LP

BioFlorida Conference

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PURDUE PHARMA LP

BioFlorida Conference

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RLD : Yes

TE Code : AB

BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 10MCG/HR

Approval Date : 2010-06-30

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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PURDUE PHARMA LP

BioFlorida Conference

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PURDUE PHARMA LP

BioFlorida Conference

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RLD : Yes

TE Code : AB

BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 20MCG/HR

Approval Date : 2010-06-30

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

PURDUE PHARMA LP

BioFlorida Conference

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PURDUE PHARMA LP

BioFlorida Conference

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Digital Content

RLD : Yes

TE Code : AB

BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 15MCG/HR

Approval Date : 2013-07-25

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

PURDUE PHARMA LP

BioFlorida Conference

Not Confirmed

PURDUE PHARMA LP

BioFlorida Conference

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Digital Content

RLD : Yes

TE Code : AB

BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 7.5MCG/HR

Approval Date : 2014-06-30

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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